Teicoplanin Allergy Testing Using Autologous Serum (TATAS)

Официальное название

Improving The Sensitivity of Teicoplanin Allergy Testing By Using Autologous Serum

Обзор

Allergy testing for Teicoplanin is much more unreliable than for other similar drugs. This means that we run the risk of missing serious Teicoplanin allergy, and these patients will be given another dose in future, not knowing that they are seriously allergic. Serious allergic reactions, also known as anaphylaxis, can be life threatening. The patients which we recruit to our study will come to us through the perioperative allergy service. They will have had a reaction to a general anaesthetic, but will also have had teicoplanin as part of the anaesthetic. We are not sure why allergy skin testing, which is fairly reliable for most other drugs, is so unreliable in detecting teicoplanin allergy. We do know that some drugs need to mix with proteins in the blood before they trigger an allergy. We would like to replicate this by mixing the teicoplanin with the patients' own blood and using this for the skin testing, to see if we get a more reliable result compared with the plain drug. Using the patient's own serum to do skin testing is an established test (the 'autologous serum test') used in certain immunological conditions, we are simply going to use it as a vehicle to test our theory. We will recruit 20 adult patients referred with a recent history of anaphylaxis under anaesthesia, where teicoplanin has been given and is one of the drugs under suspicion of having caused the allergy. In addition to the usual allergy skin testing, which would be done anyway as part of standard allergy investigation, we will perform extra tests using autologous serum for this trial. We hope to find a better way of testing for Teicoplanin allergy, so that patients are not put at risk where the allergy has been missed because of an unreliable test.

Вмешательства

• Диагностический тест Teicoplanin Allergy Testing using autologous serum
  In addition to performing teicoplanin allergy skin testing using standard recommended Teicoplanin concentration, we will perform skin testing using autologous serum, the supernatant which is obtained via centrifugation. Skin testing ( skin prick test and intradermal test) will be performed with these additional samples: 1. STpre: Teicoplanin added to blood sample pre-centrigufation. 2. STpost: Teicoplanin added to supernatant post-centrigufation. 3. ST0: Supernatant with no additives ( serum ne

Первичные конечные точки

• Does using autologous serum for skin testing yield more positive results as compared to using standard protocol of Teicoplanin Allergy skin test? [Срок оценки: 2 years]

Критерии участия

Критерии включения

• Adult patients 18 years old and above who have suffered suspected anaphylaxis under anaesthesia (the 'index episode'), where teicoplanin has been given

Критерии исключения

• Patients unable to stop drugs that would interfere with skin tests prior to study- e.g. antihistamines or certain anti-psychotics
• Pregnancy
• Patients under age 18 years
• Patients with elevated baseline mast cell tryptase requiring further investigation
• Patients with blood-borne viruses such as Hep B, C and HIV

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Великобритания · 1 центр

• University Hospital Southampton — Southampton

Публикации

• Liccardi G, D'Amato G, Canonica GW, Salzillo A, Piccolo A, Passalacqua G. Systemic reactions from skin testing: literature review. J Investig Allergol Clin Immunol. 2006;16(2):75-8. PMID 16689179
• Savic LC, Garcez T, Hopkins PM, Harper NJ, Savic S. Teicoplanin allergy - an emerging problem in the anaesthetic allergy clinic. Br J Anaesth. 2015 Oct;115(4):595-600. doi: 10.1093/bja/aev307. PMID 26385667

Идентификаторы

NCT: NCT06803758 · RHM CRI0456 · 345535

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗